The invention relates to systems and devices for closure of blood vessel punctures, and more particularly, the invention relates to systems and methods for facilitating hemostasis of blood vessel punctures with an absorbable sponge material.
A large number of diagnostic and interventional procedures involve the percutaneous introduction of instrumentation into a vein or artery. For example, coronary angioplasty, angiography, atherectomy, stenting of arteries, and many other procedures often involve accessing the vasculature through a catheter placed in the femoral artery or other blood vessel. Once the procedure is completed and the catheter or other instrumentation is removed, bleeding from the punctured artery must be controlled.
Traditionally, external pressure is applied to the skin entry site to stem bleeding from a puncture wound in a blood vessel. Pressure is continued until hemostasis has occurred at the puncture site. In some instances, pressure must be applied for a up to an hour or more during which time the patient is uncomfortably immobilized. In addition, a risk of hematoma exists since bleeding from the vessel may continue beneath the skin until sufficient clotting effects hemostasis. Further, external pressure to close the vascular puncture site works best when the vessel is close to the skin surface and may be unsuitable for patients with substantial amounts of subcutaneous adipose tissue since the skin surface may be a considerable distance from the vascular puncture site.
More recently, devices have been proposed to promote hemostasis directly at a site of a vascular puncture. One class of such puncture sealing devices features an intraluminal anchor which is placed within the blood vessel and seals against an inside surface of the vessel puncture. The intraluminal plug may be used in combination with a sealing material positioned on the outside of the blood vessel, such as collagen. Sealing devices of this type are disclosed in U.S. Pat. Nos. 4,852,568; 4,890,612; 5,021,059; and 5,061,274.
Another approach to subcutaneous blood vessel puncture closure involves the delivery of non-absorbable tissue adhesives, such cyanoacrylate, to the perforation site. Such a system is disclosed in U.S. Pat. No. 5,383,899.
The application of an absorbable material such as collagen or a non-absorbable tissue adhesive at the puncture site has several drawbacks including: 1) possible injection of the material into the blood vessel causing thrombosis; 2) a lack of pressure directly on the blood vessel puncture which may allow blood to escape beneath the material plug into the surrounding tissue; and 3) the inability to accurately place the absorbable material plug directly over the puncture site.
The use of an anchor and plug system addresses these problems to some extent but provides other problems including: 1) complex and difficult application; 2) partial occlusion of the blood vessel by the anchor when placed properly; and 3) complete blockage of the blood vessel or a branch of the blood vessel by the anchor if placed improperly. Another problem with the anchor and plug system involves reaccess. Reaccess of a particular blood vessel site sealed with an anchor and plug system is not possible until the anchor has been completely absorbed because the anchor could be dislodged into the blood stream by an attempt to reaccess.
Yet another approach to subcutaneous puncture closure involves the internal suturing of the blood vessel puncture with a specially designed suturing device. However, these suturing devices involve a significant number of steps to perform suturing and require substantial expertise.
The use of a bioabsorbable hemostatic foam is a promising new alternative for promoting hemostasis of a blood vessel puncture site. One example of a hemostatic foam system for facilitating hemostasis of a puncture site is described in International Publication No. WO 99/56692 which is incorporated herein by reference in its entirety. As described in this application, a pledget of compressed hemostatic foam is cut from a sheet of the foam material and is rolled into a configuration which is inserted into a delivery device. Once the foam pledget is inserted into the delivery device, the foam is hydrated, compressed, and delivered to a body for promoting hemostasis of a blood vessel puncture site.
One aspect of the present invention relates to a device for facilitating hemostasis of a puncture in the wall of a blood vessel. The device includes a delivery chamber for delivery of a sponge pledget into a patient to seal a puncture, a pusher positioned in a proximal end of the introducer for ejection of the pledget from the delivery chamber into the patient to seal the puncture, and a staging chamber removably connectable to a distal end of the delivery chamber for hydrating the sponge pledget and delivering the sponge pledget to the delivery chamber, the staging chamber having a lumen diameter which is larger than a lumen diameter of the delivery chamber.
In accordance with another aspect of the present invention, a connector for introducing fluid to a chamber includes a connector body, a releaseable coupling for coupling a first end of the connector body to the opening of the chamber, a sealing mechanism for forming a substantially fluid tight seal between the first end of the connector body and the opening of the chamber, and a lock mechanism for preventing the release of the releaseable coupling when a syringe is connected to a second end of the connector body.
In accordance with an additional aspect of the present invention, a staging system for hydrating a sponge pledget includes a staging chamber having an open lumen with a tapered section at a first end, and a connector attachable to a second end of the staging chamber for connecting a syringe to the staging chamber. The connector includes a connector body having a central lumen, a first end for connection to the staging chamber, and a second end for connection to a syringe, a releasable coupling for coupling the first end of the connector body to the staging chamber, and a sealing mechanism for forming a substantially fluid tight seal between the first end of the connector and the staging chamber.
In accordance with a further aspect of the present invention, a device for facilitating hemostasis of a puncture in the wall of a blood vessel includes a delivery cannula for delivery of a sponge pledget into a patient to seal a puncture, a pusher positioned in a proximal end of the delivery cannula for ejection of the pledget from the delivery cannula into the patient to seal the puncture, and a staging chamber having a first end removably connectable to the delivery cannula. The staging chamber has a valve with a first position for hydrating the sponge pledget and a second position for delivering the sponge pledget to the delivery cannula. The staging chamber has a lumen diameter which is larger than a lumen diameter of the delivery cannula.